Clinical use of a 180-day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes.
Concetta Irace, Antonio Cutruzzolà, Annamaria Nuzzi, Roberta Assaloni, Barbara Brunato, Dario Pitocco, Linda Tartaglione, Sergio Di Molfetta, Angelo Cignarelli, Luigi Laviola, Giuseppe Citro, Elisabetta Lovati, Agostino Gnasso, Katherine S Tweden, Francine R Kaufman
Author Information
Concetta Irace: Department of Health Science, University Magna Graecia, Catanzaro, Italy.
Antonio Cutruzzolà: Department of Clinical and Experimental Medicine, University Magna Graecia, Catanzaro, Italy.
Annamaria Nuzzi: Diabetologia ed Endocrinologia ASL CN2, Alba Bra, Italy.
Roberta Assaloni: SSD di Diabetologia, AAS2 Bassa Friulana-Isontina, Italy.
Barbara Brunato: SSD di Diabetologia, AAS2 Bassa Friulana-Isontina, Italy.
Linda Tartaglione: UOSA Diabetologia, Fondazione IRCCS, University Agostino Gemelli, Rome, Italy.
Sergio Di Molfetta: Medicina Interna, Endocrinologia, Andrologia e Malattie Metaboliche, D.E.T.O., Università degli Studi di Bari "Aldo Moro", Bari, Italy.
Angelo Cignarelli: Medicina Interna, Endocrinologia, Andrologia e Malattie Metaboliche, D.E.T.O., Università degli Studi di Bari "Aldo Moro", Bari, Italy. ORCID
Luigi Laviola: Medicina Interna, Endocrinologia, Andrologia e Malattie Metaboliche, D.E.T.O., Università degli Studi di Bari "Aldo Moro", Bari, Italy.
Giuseppe Citro: UOSD Diabetologia ed Endocrinologia ASP, Potenza, Italy.
Elisabetta Lovati: Clinica Medica I, Fondazione IRCCS, University San Matteo, Pavia, Italy.
Agostino Gnasso: Department of Clinical and Experimental Medicine, University Magna Graecia, Catanzaro, Italy.
Katherine S Tweden: Senseonics Inc., Germantown, Maryland, US. ORCID
Francine R Kaufman: Senseonics Inc., Germantown, Maryland, US.
AIMS: This real-world study evaluated the changes in glycated haemoglobin (HbA1c) and continuous glucose monitoring (CGM) metrics associated with use of the implantable 180-day Eversense CGM System (Eversense) in patients with type 1 diabetes. MATERIALS AND METHODS: This was a prospective, multicentre, observational study among adult participants aged ≥18 years with type 1 diabetes across seven diabetes-care centres in Italy who had Eversense inserted for the first time. HbA1c was measured at baseline and at 180 days. Changes in time in range [TIR (glucose 70-180 mg/dL)], time above range [TAR (glucose >180 mg/dL)], time below range [TBR (glucose <70 mg/dL)] and glycaemic variability were also assessed. Data were also analysed by previous CGM use and by mode of insulin delivery. RESULTS: One-hundred patients were enrolled (mean age 36 ± 12 years, mean baseline HbA1c 7.4 ± 0.92% [57 ± 10 mmol/mol]). Fifty-six per cent of patients were users of the continuous subcutaneous insulin infusion pump and 45% were previous users of CGM. HbA1c significantly decreased in patients after 180 days of sensor wear (-0.43% ± 0.69%, 5 ± 8 mmol/mol, P < 0.0001). As expected, CGM-naïve patients achieved the greatest reduction in HbA1c (-0.74% ± 0.48%, 8 ± 5 mmol/mol). TIR significantly increased and TAR and mean daily sensor glucose significantly decreased while TBR did not change after 180 days of sensor wear. CONCLUSIONS: Real-world clinical use of the Eversense CGM System for 180 days was associated with significant improvements in HbA1c and CGM metrics among adults with type 1 diabetes. The study is registered on clinicaltrials.gov (NCT04160156).
Associated Data
ClinicalTrials.gov | NCT04160156
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